Past Meetings

There will be two topics presented to the committee for their discussion and consideration. During the first session, the Office of Pharmaceutical Science and the Office of Compliance will discuss with the committee the use of statistical methods for the evaluation of pharmaceutical product quality. The committee will receive presentations from the Agency on the need for objective metrics of product quality and some of the available statistical methods used by other industries in their quality assurance programs. Representatives from the pharmaceutical industry will provide the manufacturers' perspective.
During the second session, the committee will receive an update and status on research activities within the Office of Pharmaceutical Science supporting regulatory decision making. There will be presentations from the Office of Generic Drugs, the Office of Testing and Research, and the Office of Biotechnology Products. This will be an awareness topic and there will not be formal committee discussion or recommendation.

During the morning session, the committee will discuss FDA’s draft guidance on tablet scoring. This topic will include an overview of FDA’s proposed plan to move forward and the United States Pharmacopoeia’s perspective on the topic. During the afternoon session, the committee will discuss: (1) The Center for Drug Evaluation and Research (CDER) Nanotechnology Risk Management Working Group activities; (2) nanotechnology-related research conducted and published by CDER, to include examples related to sunscreens; and (3) the overview and preliminary analysis of nanotechnology-related information collected from drug application submissions.

During the first session, the committee will discuss the uses and limitations of in vitro dissolution testing and propose future direction for evaluation including possible research. During the second session, the committee will receive an update on the FDA’s recently posted draft guidances for industry on biosimilar products. This will be an awareness topic and there will not be formal Committee discussion or recommendation.

The committee will discuss the clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development. FDA will seek input on how to strategically inform pediatric clinical trial design and dosing by utilizing existing knowledge, including available adult and nonclinical data. The discussion will include the role of modeling and simulation including physiologically-based pharmacokinetic modeling in pediatric drug development. Modeling and simulation is the application of mathematical approaches to predicting what will happen in a clinical trial with pediatric patients when a particular dose of a drug is used.

The committee will discuss presentations by the Office of Generic Drugs (OGD) on bioequivalence issues and quality standards relative to narrow therapeutic index (NTI) drug products as a class. In response to feedback during the April 13, 2010, Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS-CP) meeting, the committee will further discuss the definition and list of NTI drugs, as well as proposed bioequivalence standards for these products. The committee will also receive awareness presentations relevant to OGD’s ongoing focus on quality and safety of generic drug products. Presentations will outline current activities seeking to better understand the impact of formulation and quality on the performance of generic drug products and current thinking related to potential regulatory pathways for these issues.

The committee will discuss innovative approaches to the development of drugs for orphan and rare diseases to support decisions such as dose and trial design selection. FDA will seek input and comment on how to optimally utilize mechanistic biomarkers and apply clinical pharmacology tools, such as pharmacogenetics and modeling and simulation, to facilitate efficient and informative drug development and regulatory review. FDA will present and seek input from the committee on how lessons learned from other applications of clinical pharmacology tools in pediatrics and oncology can be applied to orphan and rare disease drugs. The committee will be asked to comment on the current status and future direction for clinical pharmacology studies (e.g., dose-response, drug-drug interactions, pharmacokinetics in patients with renal or hepatic impairment) as they pertain to drug development for orphan and rare diseases

On April 14, 2010, the committee will: (1) Receive presentations from the Office of Generic Drugs (OGD) on a proposal for revision of the bioequivalence (BE) approaches, specifically to discuss the addition of a limitation on point estimates; (2) receive presentations on an awareness topic to highlight some issues associated with product instability (failure of a marketed product to meet stability specifications through the expiration date), and the potential research needs to address those issues; and (3) receive and discuss presentations from Office of Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive intracellular accumulation of phospholipids, a kind of fatty molecule, due to the use of certain drugs).

On April 13, 2010, the committee will receive presentations from the Office of Generic Drugs and discuss two bioequivalence topics relevant to generic drug approval: (1) Revising the BE approaches for critical dose drugs and (2) the use of partial area under the curve (AUC) for the evaluation of abbreviated new drug applications for products with complex pharmacokinetic profiles. Bioequivalence refers to the evaluation of equivalence in the rate and extent of drug absorption between two preparations of the same drug. Critical dose drugs are medicines that require a narrow (or ``critical'') dose range to achieve and maintain their intended effects and to reduce serious adverse drug reactions. The ``area under the curve'' is the area under a plot of drug concentration in the bloodstream versus time; it is a measure of the extent of exposure to a drug after a dose is administered.

The committee will: (1) Receive a status update from the Office of Generic Drugs (OGD) on bioequivalence for highly variable drugs (highly variable means that the rate and amount of the drug entering blood varies significantly from one administration to another); (2) receive presentations from the Office of Pharmaceutical Science (OPS) on the scientific and regulatory challenges of Transdermal Drug Delivery Systems (TDDS); (3) receive presentations from OPS and discuss current thinking on ‘‘Classifying Pre-Surgical Preparations as Sterile Products’’ in consideration of how these products are used; and (4) be updated by OPS on the current status of the International Conference on Harmonization (ICH) Quality Topics [i.e., those relating to chemical and pharmaceutical quality assurance (stability testing, impurity testing, etc.)], and outline the role of the ICH Implementation Work Group (Q IWG), its future activities, and any remaining gaps and challenges.

On July 22, 2008, the committee will do the following: (1)Receive presentations from the Office of Pharmaceutical Science (OPS) and discuss current thinking on issues pertaining to the use of nanotechnology in drug manufacturing, drug delivery, or drug products, and (2) receive an update from OPS, discuss, and make comments on current strategies and directions for the testing of lead in pharmaceutical products. On July 23,2008, the committee will do the following: (1)Receive and discuss presentations from the Office of Generic Drugs (OGD) on the bioequivalence methods for locally acting drugs that treat gastrointestinal (GI) conditions, (2) receive and discuss presentations from OGD on the use of inhaled corticosteroid dose-response as a means to establish bioequivalence of inhalation drug products, and (3) receive and discuss presentations from OPS on the drug classification of orally disintegrating tablets (ODT) as a separate dosage form, and the need for subsequent guidance on expectations and recommendations that would be required for applications proposing the dosage form.

On March 18, 2008, the committee will: (1) Discuss and provide comments on three new topics of this meeting; first new topic: The new clinical pharmacogenomics (PGx) concept paper. Key issues in the concept paper include an industry survey on the collection of PGx samples, and the applications of PGx in clinical development will be presented and (2) discuss and provide comments on the second new topic: Quantitative clinical pharmacology: Critical path opportunities. An example of a disease model and its applications will be presented. The regulatory experience, designs, and implications of pediatric studies will be discussed. On March 19, 2008, the committee will consider the third new topic: Renal impairment concept paper. The effects of renal impairment on Cytochrom P (CYP)/transporter, methods of evaluation of renal function, and the effects of hemodialysis on drug clearance will be discussed.

On May 1, 2007, the committee will do the following: (1)
Receive and discuss updates from the October 18 and 19, 2006, Clinical
Pharmacology Subcommittee Meeting and the April 30, 2007, Manufacturing
Subcommittee Meeting; (2) receive an update, discuss and make comments
on current strategies and directions for the Critical Path Initiative;
(3) receive an update and discuss revisions to the FDA draft guidance
for industry entitled ``Comparability Protocols -- Chemistry,
Manufacturing, and Controls Information;'' (4) discuss current thinking
on risk-based approaches to managing post-approval activity. On May 2,
2007, the committee will do the following: (1) Receive an update from
the Office of Generic Drugs (OGD) on the bioequivalence of highly
variable drugs, (2) receive an update on and discuss general strategies
within the OGD pertaining to the bioequivalence of narrow therapeutic
index drug products, and (3) discuss and provide comments on the topic
of alcohol-induced dose dumping.

The subcommittee will do the following: (1) As an awareness
topic, discuss issues pertaining to the stability of tablets split for
patient use; (2) receive a general update and discuss current
strategies on quality by design and the Office of Generic Drugs'
question-based review; and (3) receive an update on and discuss the
status of the Office of New Drug Quality Assessment Chemistry,
Manufacturing, and Controls Pilot Program.

On October 18, 2006, the subcommittee will: (1) Receive an
update on previous Clinical Pharmacology Subcommittee meeting
recommendations and an introduction to three new topics of this
meeting; (2) discuss and provide comments on the first new topic: The
scope and strength of evidence to support the inclusion of
pharmacogenetic information on Cytochrome P2D6 polymorphisms in a
revision of the label for tamoxifen to improve the benefit/risk of the
drug; and (3) discuss and provide comments on the second new topic:
evaluation of transporter-based drug interactions. On October 19, 2006,
the subcommittee will consider the third new topic: The impact of using
prior knowledge on drug development and regulatory decisions. Prior
knowledge of disease change over time and covariates, placebo variation
and drug effects can be used to make better decisions and design more
informative clinical trials. Examples will be used to demonstrate these
principles.

On October 5, 2006, the committee will: (1) Receive an
update on the International Conference on Harmonization Quality Topics
(Q8, Q9, Q10, Q4B, QOS) and discuss the impact on current regulatory
direction, and (2) receive and discuss a series of presentations from
the different offices within the Office of Pharmaceutical Science on
progress being made on quality-by-design (QBD) initiatives, followed by
presentations from the pharmaceutical industry trade associations (The
Generic Pharmaceutical Association [GPhA] and The Pharmaceutical
Research and Manufacturers of America [PhRMA]) on their QBD
perspectives and issues. On October 6, 2006, the committee will: (1)
Receive an awareness presentation on risk management for complex
pharmaceuticals, (2) receive presentations and discuss bioequivalence
issues pertaining to highly variable drugs, (3) discuss current
thinking on issues and definitions pertaining to nanotechnology, (4)
discuss implementation of definitions for topical dosage forms, and (5)
receive an update and discuss current strategies and direction for the
Critical Path Initiative.

Meeting Cancelled !!! -
On April 18, 2006, the subcommittee will: (1) Receive topic updates for ongoing activities pertaining to the International Conference on Harmonisation (ICH) Q8, Q9, Q10, and future ICH quality topics; and (2) discuss and provide comments on modernized Current Good Manufacturing Practice (CGMP) approaches to process validation that encourage continuous improvement over the product life-cycle.
On April 19, 2006, the subcommittee will: (1) Discuss and provide comments on the agency’s new approaches to Chemistry, Manufacturing, and Control (CMC) guidance development, as illustrated by the comparability protocol guidance; (2) discuss and provide comments on the CMC Pilot Program; and (3) receive an update on the Cooperative Research and Development Agreement (CRADA) with Conformia Software, Inc., to obtain information on factors influencing pharmaceutical development.

On November 14, 2005, the subcommittee will: (1) Receive an update on previous Clinical Pharmacology Subcommittee meeting recommendations and an introduction to the topics of this meeting, (2) discuss and provide comments on the evidence and process for translation of pharmacogenetic information (e.g., Cytochrome P 2C9 polymorphisms) into label updates for approved products, (3) discuss current evidence related to the pharmacogenetics of warfarin as a potential basis for label updates, and (4) discuss and provide comments on the critical path pilot project, the End-of-Phase 2A meetings which will include a case study.
On November 15, 2005, the subcommittee will discuss and and provide comments on: (1) An update on the critical path biomarker-surrogate endpoint project, (2) the use of biomarker information in labels to facilitate individualizing pharmacotherapy, and (3) the analytical and clinical validation criteria for approving a clinical assay ("diagnostic test").

On October 25, 2005, the committee will do the following: (1) receive an update on current activities of the Parametric Tolerance Interval Test Workgroup; (2) receive and discuss presentations from the Pharmaceutical Research and Manufacturing Association, the Generic Pharmaceutical Association, and the United States Pharmacopeia pertaining to their perspectives on the general topic of Quality-by-Design (QBD) and drug release or dissolution specification setting; and (3) discuss and provide comments on the updated tactical plan under development for the establishment of drug release or dissolution specifications.
On October 26, 2005, the committee will do the following: (1) discuss and provide comments on the general QBD topics of question-based review and alcohol-induced dose dumping; and (2) receive and discuss an update on the establishment of a workgroup for the review and assessment of Office of Pharmaceutical Science research programs. Following those items, an awareness topic will be introduced concerning the need to enhance the pharmaceutical education system in the United States.

On May 3, 2005, the committee will: (1) Receive an update from the Clinical Pharmacology Subcommittee and (2) discuss and provide comments on the general topic of establishing drug release or dissolution specifications.
On May 4, 2005, the committee will: (1) Receive an update on current activities of the Parametric Tolerance Interval Test Workgroup, (2) discuss and provide comments on the general topic of considerations for assessment of pharmaceutical equivalence and product design, and (3) discuss criteria for establishing a working group for review and assessment of Office of Pharmaceutical Science research programs.

On November 3, 2004, the subcommittee will: (1) Receive topic updates for ongoing FDA activities previously presented to the subcommittee; (2) discuss and provide comments on the evidence for updating labels of approved drugs to include integrating pharmacogenetic, pharmacokinetic, and prognostic biomarkers for the purpose of optimizing therapeutic response and reducing risks of toxicity; and (3) discuss and provide comments on metabolism- and transporter-based drug-drug interactions included as recommendations in a draft guidance for industry being prepared by FDA.
On November 4, 2004, the subcommittee will discuss and provide comments on a new critical path project related to general aspects of the transition of biomarkers to surrogate endpoints, with a focus on planning and process, rather than on specific biomarkers or surrogate endpoints.

On October 19, 2004, the committee will do the following: (1) receive updates pertaining to the Manufacturing Subcommittee, the Parametric Tolerance Interval Test (PTIT) Workgroup, and the Good Manufacturing Practices (GMPs) for the 21st Century Initiative, and (2) review and discuss research opportunities under the Critical Path Initiative.
On October 20, 2004, the committee will do the following: (1) review and discuss the Office of Pharmaceutical Science (OPS) plans and activities designed to take the organization towards the ‘‘desired state’’ of science and risk-based regulatory policies and practices as articulated under the GMPs for the 21st Century Initiative, and (2) review and discuss specific topics related to pharmaceutical equivalence and bioequivalence of generic drugs.

On July 20, 2004, the subcommittee will address the
following issues: (1) Receive topic updates for ongoing activities
pertaining to manufacturing science and quality by design; and (2)
discuss and provide comment on a Current Good Manufacturing Practice
(cGMP) risk model being developed at FDA. On July 21, 2004, the
subcommittee will address the following issues: (1) Discuss and provide
comments on a cGMP and quality system approach for the production of
investigational new drugs (INDs) and (2) discuss and provide comments
on manufacturing science and risk-based questions for new drug
application chemistry, manufacturing and controls (NDA CMC) review
process.

On April 13, 2004, the committee will receive an update from the Clinical Pharmacology Subcommittee. The committee will also discuss and provide comments on the following topics: (1) a proposal for resolving the issues related to the parametric tolerance interval test for dose content uniformity for inhalation products, (2) the Process Analytical Technologies progress and next steps, and (3) process analytical technology for products in the Office of Biotechnology Products, Center for Drug Evaluation and Research and in the Center for Biologics Evaluation and Research.
On April 14, 2004 the committee will discuss and provide comments on the following topics: (1) Bioequivalence testing/methods strategy for products exhibiting high variability and (2) bioinequivalence concepts and definition

On November 17, 2003, the subcommittee will discuss:
(1) Quantitative analysis using exposure-response: Proposal for End-of-Phase2A (EOP2A) meeting and use of clinical trial
simulation for PK-QT study design; and
(2) pediatric decision tree: Examples for applying the pediatric decision tree.
On November 18, 2003, the subcommittee will discuss the pediatric decision tree: (1) Use of clinical trial simulation in
pediatric population pharmacokinetics study design;
(2) drug interactions; and
(3) pharmacogenetics: Integration into new drug development.

On October 21, 2003, the committee will:
(1) receive updates from the Manufacturing, Clinical Pharmacology, and Pharmacology/Toxicology Subcommittees;
(2) discuss and provide comments on draft FDA Guidance for Industry entitled, "Process Analytical Technologies (PAT) - A
Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance," see the FDA internet web address
www.fda.gov/cder/guidance/5815dft.htm; and
(3) discuss and provide comments on parametric tolerance interval test for dose content uniformity.
On October 22, 2003, the committee will:
(1) discuss and provide comments on risk based Chemistry Manufacturing and Control review proposals;
(2) discuss and provide comments on nomenclature; and
(3) discuss and provide direction to the research plan for generics.

On September 17, 2003, the subcommittee will discuss quality by design and how it is distinct from the approaches that attempt to test in qualities. On September 18, 2003, the subcommittee will discuss and define principles by which risk management is integrated into decision making.

The committee will review and discuss issues relating to the format and content of
genome scale gene expression data generated during nonclinical pharmacology and toxicology
investigations and the submission of this data to the agency.

On May 21, 2003, the subcommittee will discuss: (1) The mission of the subcommittee; and (2) direction of the Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century: A Risk-Based Approach.
On May 22, 2003, the subcommittee will discuss: (1) The regulatory approaches regarding aseptic manufacturing; and (2) process analytical technologies and transition from the Advisory Committee for Pharmaceutical Science-Process Analytical Technologies Subcommittee to Manufacturing Subcommittee.

On April 22, 2003 the subcommittee will dicuss (1) quanitative risk benefit analysis using exposure
response for determining dose adjustment for
special populations and (2) pediatric population
pharmacokinetic study design template and analysis of the FDA pediatric database.
On April 23, the subcommittee will discuss pharmacogenetics improvement of drug treatments
2 drug interactions metabolism and transport based.

The subcommittee will discuss: (1) Consideration of
investigational pharmacokinetic studies to identify patient populations
at risk, (2) methods used to adjust dosing given the availability of
exposure-response information, (3) use of exposure-response
relationships in the Pediatric Study Decision Tree, (4) questions to be
asked of the pediatric database, and (5) scientific and practical
considerations in the use of pharmacogenetic tests to determine drug
dosage and administration.

On September 9, 2002, the Chair of the expert working group
on cardiotoxicity will report on the progress and activities of the
group and the subcommittee will be allotted time to discuss the report.
The subcommittee will then discuss a plan to transfer oversight of the
subcommittee from the Advisory Committee for Pharmaceutical Science to
the Science Advisory Board of the National Center for Toxicological
Research. On September 10, 2002, the Chair of the expert working group
on vascular damage will report on the progress and activities of the
group and the subcommittee members will be allotted time to discuss the
report.

On June 12 2002, the subcommittee will: (1) Identify
and define technology and regulatory uncertainties/hurdles, possible
solutions, and strategies for the successful implementation of process
analytical technologies (PATs) in pharmaceutical development and
manufacturing; (2) discuss general principles for regulatory
application of PATs including principles of method validation,
specifications, use and validation of chemometric tools, and
feasibility of parametric release concept; and (3) discuss the need for
a general FDA guidance to facilitate the implementation of PATs.
On June 13, 2002, the subcommittee will discuss strategies to
explore issues in the following four focus areas: (1) Product and
process development, (2) process and analytical validation, (3)
chemometrics, and (4) process analytical technologies, applications and
benefits.

On February 25, 2002, the subcommittee will: (1) Identify
and define technology and regulatory uncertainties/hurdles, possible
solutions, and strategies for the successful implementation of process
analytical technologies (PATs) in pharmaceutical development and
manufacturing; (2) discuss general principles for regulatory
application of PATs including principles of method validation,
specifications, use and validation of chemometric tools, and
feasibility of parametric release concept; and (3) discuss the need for
a general FDA guidance to facilitate the implementation of PATs.
On February 26, 2002, the subcommittee will discuss strategies to
explore issues in the following four focus areas: (1) Product and
process development, (2) process and analytical validation, (3)
chemometrics, and (4) process analytical technologies, applications and
benefits.

On November 28, 2001, the committee will: 1) discuss the current
status of, and future plans for, the draft FDA guidance entitled "ANDAs: Blend
Uniformity Analysis, 2) discuss and provide direction for the process Analytical
technology Subcommittee, 3) discuss and provide comments on stability testing and
shelf-life, and 4) receive updates from subcommittees and on other CDER guidance
documents. On November 29, 2001, the committee will: 1) receive updates on FDA
research in dermatopharmacokinetics and 2) discuss and provide comments on
bioequivalence issues.

The subcommittee will discuss the
activities of the two expert working groups requested by this
subcommittee: The working group on biomarkers of cardiac
tissue injury and the working group on biomarkers of vasculitis
(vascular damage). Representatives from each working group
will report their progress and plans, and the subcommittee will
discuss these activities and provide feedback to the working
groups. Administrative oversight of the subcommittee will be
discussed, including the possibility of integration with the
Scientific Advisory Board of the FDA National Center for
Toxicological Research.

On July 19, the committee will (1)
Discuss specific recommendations of the Orally Inhaled and
Nasal Drug Products Subcommittee regarding dose response
of locally acting nasal sprays and nasal aerosols, with particular
application to bioequivalence studies; (2) hear reports and
provide direction to the Nonclinical Studies Subcommittee; (3)
provide comments and advice to the Risk-Based Chemistry,
Manufacturing, and Controls Review Working Group for
establishment of a list of low risk drugs; (4) discuss and provide
direction on optimal applications of inline process controls in
pharmaceutical production; and (5) discuss problems and
provide comments to form a scientific basis for establishment
of acceptance limits for microbiological tests that use newly
developed technologies that do not rely on colony counts, and
their application as process controls and product release
criteria. On July 20, the committee will (1) Provide comments
and advice on methods to determine drug transfer into breast
milk and interpretation of data; and (2) discuss and provide
comments on the feasibility, scientific challenges, and
approaches for establishment of pharmaceutical equivalence,
bioavailability, and bioequivalence of liposome drug products.

On November 17, 2000, the committees will discuss the current status of, and future plans for, the draft FDA guidance entitled ``A Guidance for Industry, Topical Dermatological Drug Product
NDA's and ANDA's--In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies;'' A proposed research program for addressing scientific issues related to this guidance will also be discussed.

On November 15, 2000, the committee will: (1) Discuss approaches to reducing the regulatory burden for chemistry, manufacturing, and controls supplements; and (2) hear reports and provide direction to the Advisory Committee for Pharmaceutical Science's Subcommittee on Orally Inhaled and Nasal Drug Products, and to the Subcommittee on Nonclinical Studies. On November 16, 2000, the committee will: (1) Discuss the FDA guidance entitled ``A Guidance for Industry, Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System,''

The subcommittee will discuss specific scientific issues where the additional expertise of the subcommittee is needed to aid the agency in refining draft guidances for orally inhaled and nasal drug products in the areas of: (1) Chemistry, manufacturing, and controls; and (2) in vitro and in vivo bioavailability/bioequivalence.

The subcommittee meeting will discuss collaborative approaches to scientific research issues of common interest to the pharmaceutical industry, universities, the public, and FDA. Specific areas of focus will be in the nonclinical studies areas of: (1) Interspecies biomarkers of toxicity and (2) noninvasive imaging.

The subcommittee will discuss collaborative approaches to scientific research issues of common interest to the pharmaceutical industry, universities, the public, and FDA. Specific areas of focus will be in the nonclinical studies areas of: (1) Interspecies biomarkers of toxicity, (2) high-resolution magnetic imaging, (3) positron emission tomography imaging, and (4) methods to facilitate early human assessments.

On Sept. 23, the committee will discuss individual bioequivalence-
criteria for equivalence comparisons.
On Sept. 24, the committee will discuss clinical pharmacology-
pharmacokinetic/pharmacodynamic issues in drug development and
research issues in nonclinical studies.

October 22nd will be devoted to discussion on bioavailability/bioequivalence (BA/BE) issues related to solid oral dosage forms. Discussion will also include progress reports on guidances pertaining to the biopharmaceutical classification system, other BA/BE guidances, and criteria (average, population, and individual) to allow comparison of BE measures/parameters.

On June 23 and 24, 1998, the Committee will focus on both safety/efficacy and quality topics with a bridging topic (exposure). Specific topis to be discussed include nonclinical/nonhuman pharmacology/toxicology research programs to support the drug development and registartion process, in vitro drug metabolism to support guidance updating; the revision of the guidance for scale-up and post-approval changes for immediate release drug products; and complex drug substances.

On December 11, 1997, the committee will discuss the
Biopharmaceutics Classification System, topicals-dermatological drug
products, and Narrow Therapeutic Index Drugs and relevance to product
quality testing. On December 12, 1997, the committee will discuss the
drug-drug interaction studies, and bioequivalence studies that fail to
meet established confidence intervals.

On August 15, 1996, the committee will
discuss the Biopharmaceutics Drug Classification System and Individual
Bioequivalence. On August 16, 1996, the committee will discuss Product
Quality Research, Laboratory-Based Clinical Pharmacology Research, and
Clinic-Based Clinical Pharmacology Research.

Upcoming Meetings

Recent Meetings

The committee will discuss biologics license application 125547, necitumumab injection, application submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.